The EU Declaration of Conformity is the formal self-certification statement that a provider of a high-risk AI system must draw up before placing the system on the EU market. It is governed by Article 47 of Regulation (EU) 2024/1689, with the mandatory content specified in Annex V.
Unlike many compliance documents, the Declaration of Conformity is not a lengthy technical report — it is a concise, structured declaration. But "concise" does not mean simple. Every element specified in Annex V is mandatory, and a generic template that does not reference your specific system, version, and applicable conformity assessment procedure will not satisfy the regulation.
The Declaration of Conformity cannot stand alone. It must be appended to your Article 11 Technical Documentation and cross-reference the conformity assessment procedure under Article 43 that was applied. Without those supporting documents, the declaration is legally incomplete.
Any provider of a high-risk AI system as defined under Article 6 — meaning systems listed in Annex III, or AI systems that are safety components of products subject to Annex I — must draw up an EU Declaration of Conformity before the system is placed on the market or put into service within the EU.
Deployers — companies that use a third-party high-risk AI system without modifying it — do not draw up a Declaration of Conformity. That obligation rests with the provider. However, if a deployer substantially modifies the system, they become a provider under Article 25 and must draw up their own declaration.
Annex V specifies exactly what the Declaration of Conformity must contain. All six elements are mandatory — omitting any one of them renders the declaration non-compliant.
The declaration must identify the AI system by its exact commercial name and model designation, plus any additional unambiguous reference enabling identification. For versioned software systems, the version number is essential — the declaration is valid for that specific version, not all versions of the product. If you release v2.0 after drawing up a declaration for v1.3, you must draw up a new declaration for v2.0 if the changes are material.
The full legal name and registered address of the provider — the company placing the system on the market — must appear on the declaration. If the provider is established outside the EU, the name and address of the EU-based authorised representative under Article 22 must also be included.
The declaration must include a statement that the provider takes sole responsibility for the conformity of the AI system with Regulation (EU) 2024/1689. This is a legal commitment — it is the provider declaring, under their own authority, that all obligations under the regulation have been met. This is why the declaration must be signed by an authorised representative of the company, not a generic document generator output.
This section identifies the AI system in sufficient detail to allow identification — typically the system name, version, intended purpose, and the Annex III category it falls under. The intended purpose stated here must be consistent with the intended purpose described in the Article 11 Technical Documentation. Inconsistencies between these two documents are a significant compliance risk.
The declaration must state that the described AI system is in conformity with Regulation (EU) 2024/1689 and, where relevant, with any other Union legislation that may apply. For AI systems that are safety components of products under Annex I — such as medical devices or machinery — the declaration must also reference the applicable product safety legislation and the harmonised standards applied.
Any harmonised standards or common specifications applied during the conformity assessment must be listed with their reference numbers and dates. If no harmonised standards were applied — which is currently the case for most providers, as the harmonised standards under the AI Act are still being developed — the declaration must reference the alternative technical solutions adopted.
The declaration must also reference which conformity assessment procedure under Article 43 was followed. For most Annex III high-risk AI systems, this is internal control per Annex VI — meaning the provider self-certifies compliance without involving a third-party notified body. The exceptions where a notified body is required include AI systems used for remote biometric identification and certain safety-critical systems under Annex I.
Getting the conformity assessment reference wrong — or omitting it — is a common error in generic templates. The declaration must be specific about which procedure was applied and, if a notified body was involved, their identification number.
Below is a structured template based on the Annex V requirements. Fields in brackets must be completed with your system-specific information. This template is a starting point — it must be reviewed by qualified legal counsel before use.
A declaration of conformity generated from a generic template — without system-specific details, a correct conformity assessment procedure reference, and an authorised signatory — is legally worthless. National competent authorities reviewing a declaration will check it against the Article 11 Technical Documentation. If the system name, version, intended purpose, or Annex III category differs between the two documents, the provider is exposed to enforcement action.
More importantly, the declaration must be consistent with the actual conformity assessment that was performed. Drawing up a declaration that claims conformity under Annex VI internal control when the system actually required notified body involvement is a serious compliance failure, not a paperwork issue.
The EU AI Act Compliance Pack Generator produces an Article 47 Declaration of Conformity as part of the full three-document pack — alongside the Article 11 Technical Documentation and Article 13 Instructions for Use. The declaration is generated from your system-specific inputs, formatted to Annex V requirements, and delivered as a professional PDF with cover page and signing section.
The full pack is $197 one-time. No account, no subscription. You review the generated declaration with your legal team, fill in the signatory details, and retain it as part of your technical documentation file.
System-specific Article 47 declaration, bundled with Article 11 Technical Documentation and Article 13 Instructions for Use — $197 one-time.
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No. Article 47(1) requires a separate Declaration of Conformity for each high-risk AI system. If you operate five AI systems that fall under Annex III, you need five separate declarations, each referencing the specific system's technical documentation.
Yes. Under Article 47(3), the declaration must be translated into the official languages required by the member states in which the system is made available. For EU-wide deployment, you should have the declaration available in all relevant EU languages, or at minimum in the languages required by the member states where the system is placed on the market.
Article 18 requires the declaration to be retained for 10 years after the system is placed on the market or put into service. If the system is withdrawn from the market, the 10-year retention period still applies from the date of last placement.
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Deadline: August 2, 2026
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